Temperature Probe/Sensor
A generic term used to describe any type of temperature measuring device that works through contact with the material or atmosphere to be measured. [Synonyms: Load Probe, Heat Penetration Probe, Temperature Distribution Probe, Drain Probe] (TR48)
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Temperature Distribution
Temperature measurement of the heating medium (e.g., forced hot air) across the chamber load zone. (TR01) (TR03) (TR30) (TR48)
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Site Acceptance Testing
The SAT is a series of tests that are performed as part of commissioning after the unit has been installed in the final location. (TR48)
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Steam: Plant Steam
Steam of undefined chemical or biological quality produced from a boiler, usually containing boiler additives, without further treatment. [Synonym: Factory Steam, House Steam, Industrial Steam] (TR48)
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Steam: Pure Steam
Collected condensate that complies with the Compendial requirements for Water for Injecton (WFI). [Synonyms: clean steam, high quality steam] (TR01) (TR61) (TR48)
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Steam: Process Steam
Process steam is similar to plant steam, except the steam is generated using a controlled feed water source to which no volatile additives (amines or hydrazines) have been introduced. Process steam may be appropriate for moist heat sterilization of liquid loads where the containers are filled and sealed prior to sterilization. (TR48)
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Sterilizer Specification (User Requirement Specification (URS))
A description of features and performance requirements of a system that will fulfill the needs of the end user. (TR48)
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Sterilizer Specification (Design Specification (DS))
A set of specifications and information related to the installation features including equipment, hardware and software) of the system that will ensure the realization of the user requirements. [Synonym: Detailed Design Specification (DDS] (TR48)
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Sterilization Cycle
A sequence of defined operating parameters (e.g., time, temperature and pressure) and conditions required to render an item sterile. (TR01) (TR30) (TR48) A sequence of defined operating parameters (e.g., time and temperature) required to render an item sterile. (TR3)
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Sterilizer Specification
Documents that define sterilizer system attributes and how they should be met. (TR48)
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Resistance Temperature Detector(s) (RTDs)
Resistance temperature detectors are temperature sensors in which the electrical resistance in the element increases with increases in temperature. This electrical resistance is then translated into a temperature value (expressed as a resistance versus temperature curve). (TR48)
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Saturated Steam
Steam that is at a temperature and pressure that corresponds to the vaporization curve of water. It is in a state of equilibrium between being a liquid and a gas, with no entrained liquid water. [Synonym: Dry Saturated Steam] (TR01) (TR48) (TR61)
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Proportional Control Valve
A device that is designed for precise positioning and continuous movement, typically in response to a varying analog signal. [Synonym: Modulating Valve] (TR48)
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Programmable Logic Controller (PLC)
A digital electronic apparatus with a programmable memory for storing instructions to implement specific functions, such as logic, sequencing, timing, counting and arithmetic, to control machines and processes. (TR48)
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Operating Parameters (Critical Parameters)
Values that are controlled and/or measured and are linked to safety and efficacy of a product or the process. Failure to meet a critical parameter should result in rejection of the load. (TR01) (TR3) (TR48) (TR51)
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Operating Parameters (Key Parameters)
Values that are controlled and/or measured and are used to assure the ongoing “state of control” and consistency of runs. Failure to meet a key process parameter should result in an investigation with a documented rationale for the disposition of the load. (TR01) (TR3) (TR51) (TR48) Values that are controlled and/or measured and are used to assure the ongoing “state of control” of steam in place cycles. Failure to meet a key process parameter should result in an investigation. (TR61)
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Performance Qualification (PQ)
Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications. (TR3) (TR14) (TR45) (TR42) (TR48) (TR61) (TR64)
Transport tests of product or representative product that is conducted during actual transportation or distribution. (TR39)
Documented evidence that provides a high degree of assurance that the equipment and/or system functions accurately and consistently according to predetermined specifications in its operating environment. (TR54-5)
Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications (17). (TR60-3)
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Piping and Instrumentation Diagram (P&ID)
A schematic diagram that shows the relational arrangement of piping, components, instruments, and equipment connections of the system. It also illustrates the control and functional relationship. (TR48)
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Liquid Load
A load consisting of closed containers of aqueous liquids. The sterilization of the container contents is achieved through transfer of energy through the container into the aqueous liquid. (TR01) (TR30) (TR48)
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Load Zone
Area within the sterilization chamber where materials to be sterilized may be placed. (TR01) (TR3) (TR48)
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Maximum Load
The maximum quantity or mass of items permitted in a sterilizer load. (TR01) The maximum quantity or mass of items permitted in a depyrogenation or sterilization load. (TR3) The maximum quantity or mass of products permitted in a validated sterilizer load. (TR30)The maximum quantity or mass of items permitted in a sterilizer load. (TR48)
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Installation Qualification (IQ)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements. (TR14) (TR42) (TR48) (TR61) (TR64)
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations. (TR54-5)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements (17). (TR60)
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Heat-up Phase
The phase of a sterilization cycle that occurs prior to the exposure phase. Process parameters are developed for this phase in order to meet applicable user requirements for load conditioning (e.g., air removal and preheating.) (TR01) (TR3) (TR48) (TR61)
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Heat Transfer
Energy that is transferred as a result of a temperature difference between an object and its surroundings. (TR48)
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Gravity Displacement
A sterilization process based on the principle that cold air within the chamber is heavier than the steam entering and will sink to the bottom of the chamber. As steam enters the chamber, air is pushed out the bottom drain and exits, with the condensate, through a steam trap. (TR01) (TR48) (TR61)
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F-Value (Lethality Factor)
A measurement of sterilization effectiveness, the F-value is the calculated equivalent lethality (using a specified z-value), in terms of minutes at a reference temperature (Tref), delivered by a sterilization cycle. (TR1) (TR3) (TR30) (TR48) (TR61)
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Good Engineering Practice (GEP)
Documented proven and accepted engineering methods and practices that applied throughout the project life-cycle to deliver solutions that are cost effective, are compliant with regulations and meet the requirements of the user. (TR48)
Those established engineering methods and standards that are applied throughout the lifecycle to deliver appropriate and cost-effective solutions. (TR60) (TR54-5)
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Electronic Record
A record used for GMP purposes or for regulatory submission that is stored electronically for the purposes of reproduction, retrieval or archival. (TR48)
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Dryness Fraction
An absolute measure of the actual latent heat of a sample of steam relative to the theoretical latent heat of saturated steam. (TR01) (TR48)
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Eductor
A device that produces vacuum by means of the Venturi effect. [Synonym: Aspirator, ejector pump] (TR48)
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Equilibration Time
The period that elapses between the attainment of the minimum exposure temperature at the reference measurement point (typically the drain) and the attainment of the sterilization temperature at all points within the load. This period is an indication of the ability to properly remove air and heat the load items; consequently, it is typically only evaluated by placing heat penetration probes in porous/hard goods loads. (TR01) (TR48)
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Decommissioning
A planned and orderly removal of a facility, operation or system from use. (TR48)
The process of retiring equipment/systems/facilities from production use. (TR54-5)
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Discrete Control Valve
A device designed for on/off operation; fully opened or fully closed. (TR48)
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Cycle Phases
A discrete series of sterilizer process steps (such as, heat-up, exposure and cool-down) performed sequentially that represent a complete sterilization cycle. (TR48)
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Cool-Down Phase
The phase of a sterilization cycle that occurs after completion of the exposure phase. Parameters of a cool-down phase are typically defined in order to meet applicable user requirements for load cooling and drying. (TR01) The phase of a sterilization cycle that occurs after completion of the exposure phase. [Synonym: post-conditioning phase, slow exhaust phase, drying phase, equalization phase] (TR48) The phase of an SIP cycle that occurs after completion of the exposure phase. Parameters (e.g., time, temperature, pressure) of a cool-down phase are typically defined in order to meet applicable user requirements for system cooling and drying. (TR61)
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Commissioning
A well planned, documented and managed engineering approach to the start-up and transfer of facilities, systems and equipment to the end-user that results in a safe and functional environment that meets established design and user requirement specifications. Commissioning precedes Qualification and includes three phases:
1. Inspection, testing, and regulation
2. Adjustment and setting of work
3. Functional testing (TR 3)
A prescribed number of activities designed to take equipment and systems from a static, substantially complete state to an operable state. (TR 48)
A well planned, documented, managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.(TR 54) (TR 54-5)
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Chamber Leak Test
A test conducted to evaluate possible air infiltration to the chamber under vacuum. [Synonym: Vacuum Leak Test] (TR1) (TR48)
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Air Removal Test
A test used to evaluate air removal and steam penetration in an empty sterilizer that is used for porous/hard goods load sterilization (e.g., Bowie-Dick Test, DART, Lantor Cube, Browns’ Test). (TR01) (TR 48)
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Acceptance Criteria
Numerical limits, ranges, or other suitable measures for acceptance of test results. (TR 14) (TR 29) (TR 38) (TR 64)
Numerical limits, ranges, or other suitable measures for acceptance of test results. Exceeding the acceptable range for a critical parameter during subsequent validation studies may result in questionable product quality that would require initiation of an investigation. Exceeding the operating range should be documented and explained in the validation report and evaluated for validation study impact. (TR 42)
The pre-defined specifications, standards or ranges that must be met under stated test conditions. (TR 48)
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical method validation that is satisfied to determine suitability of test method performance.(TR 57) (TR 69) (TR 72) (TR 74)
The criteria that a system or component must satisfy in order to be accepted by a user or other authorized entity. (TR 54-5)
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet (16). Exceeding the acceptable range for a critical parameter during subsequent validation studies may result in questionable product quality that would require initiation of an investigation and possible batch rejection. (TR60)
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